CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Whole-food plant based diet (WFPB diet) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05181553
NCT05181553N/ACompleted

Unravelling the Impact of Diet on Cardiovascular Health in Heterozygous Familial Hypercholesterolemia: a Metabolomic Approach.

Laval University·interventional·Posted Jan 6, 2022·Updated Sep 10, 2025

In Brief

A clinical study evaluating Whole-food plant based diet (WFPB diet) and Standard North American diet (SAD diet) for Familial Hypercholesterolemia and 4 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The investigators will first conduct a fully controlled dietary randomized crossover trial (RCT) including 50 adults with HeFH to investigate the impact of a whole food plant-based (WFPB) diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome. Such a robust design will also lead to the identification an objective proxy to healthy diet adherence: the metabolomic signature. Secondly, by leveraging a cross-sectional cohort of adults with HeFH, the investigators will evaluate the relationship between the metabolomic signature of the healthy diet and cardiovascular disease risk factors in HeFH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 6, 2022
Enrollment StartJan 10, 2022
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.5 years ago

Interventions

Whole-food plant based diet (WFPB diet)other

28-day fully controlled dietary intervention during which participants will receive a whole food plant-based diet that reflects the recommendations of Canada's Food Guide.

Standard North American diet (SAD diet)other

28-day fully controlled dietary intervention during which participants will receive a diet that reflects the eating habits of Canadians.